Principles and Practice of Pharmaceutical Medicine, Third Edition

• Publisher: Wiley-Blackwell
• Year: 2010
• Tongue: English
• Leaves: 787
• Category: Library

✦ Synopsis

The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine. New content includes chapters and coverage on regulatory updates, increasing international harmonization, transitional and probabilistic approaches to drug development, the growing sophistication and regulatory importance of pharmacovigilance, personalized medicine and growth in biotechnology as a source of new experimental drugs.Content:
Chapter 1 The Practice and Practitioners of Pharmaceutical Medicine (pages 1–5): Anthony W. Fox
Chapter 2 Pharmaceutical Medicine as a Medical Specialty (pages 6–21): Michael D. Young and Peter D. Stonier
Chapter 3 Clinical Research Education and Training for Biopharmaceutical Staff (pages 22–35): Peter Marks and Sheila Gwizdak
Chapter 5 Translational Medicine, Pharmaceutical Physicians, Patients, and Payers (pages 47–57): Robert Sands and Douglas Roy
Chapter 6 Pharmaceutics (pages 58–67): Anthony W. Fox
Chapter 7 Nonclinical Toxicology (pages 68–78): Frederick Reno
Chapter 8 Informed Consent (pages 79–83): Anthony W. Fox
Chapter 9 Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure (pages 84–106): Stephen H. Curry, Helen H. Decory and Johan Gabrielsson
Chapter 10 Phase II and Phase III Clinical Studies (pages 107–123): Anthony W. Fox
Chapter 11 Phase IV Drug Development: Post?Marketing Studies (pages 124–130): Lisa R. Johnson?Pratt
Chapter 12 Site Management (pages 131–141): Barry Miskin
Chapter 13 Good Clinical Practices (pages 142–162): Lionel D. Edwards
Chapter 14 Quality Assurance, Quality Control and Audit (pages 163–181): Rita Hattemer?Apostel
Chapter 15 The Unique Role of Over?the?Counter Medicine (pages 182–193): Paul W. Starkey
Chapter 4 Drug Discovery: Design and Development (pages 39–46): Ronald R. Cobb and Leslie J. Molony
Chapter 16 Drug Research in Older Patients (pages 197–206): Lionel D. Edwards
Chapter 17 Drug Development Research in Women (pages 207–225): Lionel D. Edwards
Chapter 18 Clinical Research in Children (pages 226–232): Lionel D. Edwards
Chapter 19 Racial and Ethnic Issues in Drug Regulation (pages 233–249): Lionel D. Edwards, J?M. Husson, E. Labbe, C. Naito, M. Papaluca Amati, S. Walker, R. L. Williams and H. Yasurhara
Chapter 20 Special Populations: Hepatic and Renal Failure (pages 250–254): Anthony W. Fox
Chapter 21 Drug Interactions (pages 255–263): Anthony W. Fox and Anne?Ruth van Troostenburg
Chapter 22 Orphan Drugs (pages 264–274): Bert Spilker
Chapter 23 QT Interval Prolongation and Drug Development (pages 275–286): Bruce H. Morimoto and Anthony W. Fox
Chapter 24 Biotechnology Products and Their Development (pages 289–300): David A. Shapiro and Anthony W. Fox
Chapter 25 Health Economics (pages 301–314): Daniel C. Malone, Edward P. Armstrong and Mirza I. Rahman
Chapter 26 Pharmacoeconomics: Economic and Humanistic Outcomes (pages 315–325): Raymond J. Townsend, Jane T. Osterhaus and J. Gregory Boyer
Chapter 27 Pharmacoepidemiology and the Pharmaceutical Physician (pages 326–335): Hugh H. Tilson
Chapter 28 Statistical Principles and Application in Biopharmaceutical Research (pages 336–367): Dan Anbar
Chapter 29 Data Management (pages 368–378): T. Y. Lee, Michael Minor and Lionel D. Edwards
Chapter 30 Patient Compliance: Pharmionics, A New Discipline (pages 379–387): Dr. Jean?Michel Metry
Chapter 31 Monitoring Drug Concentrations in Clinical Practice (pages 388–392): Anthony W. Fox
Chapter 32 Generics (pages 393–398): Gabriel Lopez and Thomas Hoxie
Chapter 33 Complementary Medicines (pages 399–405): Anthony W. Fox
Chapter 34 United States Regulations (pages 409–421): William Kennedy and Lionel D. Edwards
Chapter 35 Special US Regulatory Procedures: Emergency and “Compassionate” INDs and Accelerated Product Approvals (pages 422–429): Anthony W. Fox
Chapter 36 The Development of Human Medicines Control in Europe from Classical Times to the 21st Century (pages 430–455): John P. Griffin
Chapter 37 Medicines Regulation in the European Union (pages 456–508): Anne?Ruth van Troostenburg and Giuliana Tabusso
Chapter 38 Japanese Regulations (pages 509–527): Etienne Labbe
Chapter 39 Drug Registration and Pricing in the Middle East (pages 528–534): Edda Freidank?Mueschenborn and Anja Konig
Chapter 40 China's Regulated Pharmaceutical Market (pages 535–550): Yan Yan Li Starkey
Chapter 41 India's New Era in Pharmaceuticals (pages 551–567): Darshan Kulkarni
Chapter 42 Medical Affairs (pages 571–581): Gregory P. Geba
Chapter 43 Drug Labeling (pages 582–586): Anthony W. Fox
Chapter 44 Data Mining (pages 587–600): Mirza I. Rahman and Robbert P. van Manen
Chapter 45 Risk Management in Product Approval and Marketing (pages 601–607): Anthony W. Fox
Chapter 46 Publishing Clinical Studies (pages 608–615): Anthony W. Fox
Chapter 47 Organizing and Planning Local, Regional, National, and International Meetings and Conferences (pages 616–619): Zofia Dziewanowska and Linda Packard
Chapter 48 When Things Go Wrong: Drug Withdrawals from the Market (pages 620–624): Ronald D. Mann
Chapter 49 International Trials: Successful Planning and Conduct (pages 625–633): Katie P. J. Wood
Chapter 50 Introduction to Bioethics for Pharmaceutical Professionals (pages 637–644): Andrew J. Fletcher
Chapter 51 Pharmaceutical Medicine and the Law (pages 645–654): Sarah Croft
Chapter 52 Fraud and Misconduct in Clinical Research (pages 655–665): Jane Barrett
Chapter 53 The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico?Commercial Environment (pages 669–675): R. Drucker and R. Graham Hughes
Chapter 54 Advertising and Marketing (pages 676–687): Jonathan Belsey
Chapter 55 Pharmaceutical Product Liability (pages 688–702): Han W. Choi and Jae Hong Lee
Chapter 56 Patents (pages 703–715): Gabriel Lopez
Chapter 57 Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs): Critical Success Factors (pages 716–738): John R. Vogel
Chapter 58 The Impact of Managed Care on the US Pharmaceutical Industry (pages 739–761): Robert J. Chaponis, Christine Hanson?Divers and Marilyn J. Wells